EFSA Journal最新文献

{"title":"Safety evaluation of the food enzyme alternansucrase from the genetically modified Escherichia coli strain EBASSC","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Giulio Di Piazza,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Natalia Kovalkovičová,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9331","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9331","url":null,"abstract":"<p>The food enzyme alternansucrase (sucrose:1,6(1,3)-α-<span>d</span>-glucan 6(3)-α-<span>d</span>-glucosyltransferase; EC 2.4.1.140) is produced with the genetically modified <i>Escherichia coli</i> strain EBASSC by Advanced Enzyme Technologies Ltd. The production strain of the food enzyme contains a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in the processing of sugars for the production of maltose alternan gluco-oligosaccharides. Two sets of dietary exposure estimates were made, using the default or more specific input factors. The refined dietary exposure was estimated to be up to 0.586 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 500 mg TOS/kg bw per day, the mid-dose tested, which when compared with the refined exposure estimate, results in a margin of exposure of at least 853. A search for the homology of the amino acid sequence of the alternansucrase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9331","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Jaume Galobart,&nbsp;Fabiola Pizzo","doi":"10.2903/j.efsa.2025.9341","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9341","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of a feed additive consisting of dicopper chloride trihydroxide intended for use as a nutritional additive (functional group: compounds of trace elements) for all animal species. Regarding the safety for the user, in the previous assessment, the FEEDAP Panel concluded that the additive is hazardous by inhalation, it is irritant to skin and eye and a skin and respiratory sensitiser. For the current assessment, arguments have been provided by the applicant in support of the safety of the additive for the users exposed by inhalation. The FEEDAP Panel concluded that dicopper chloride trihydroxide is irritant to skin, eyes and the respiratory system and should be considered a skin and respiratory sensitiser. Any exposure is considered a risk.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9341","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feed additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B1) for all animal species for the renewal of their authorisation (DSM Nutritional Products Ltd. and Orffa Additives BV)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Luca Tosti,&nbsp;Ruud Woutersen,&nbsp;Jaume Galobart,&nbsp;Maria Vittoria Vettori,&nbsp;Angelica Amaduzzi,&nbsp;Maria Dulak-Lis,&nbsp;Laura Iancu,&nbsp;Fabiola Pizzo,&nbsp;Eleni Gkimprixi","doi":"10.2903/j.efsa.2025.9347","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9347","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B₁ (thiamine hydrochloride and thiamine mononitrate) for the renewal of its authorisation as nutritional feed additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that vitamin B₁ remains safe for all animal species, consumers and the environment. Thiamine mononitrate is not irritant to the eyes, while hydrochloride is not irritant to skin, but it is irritant to the eyes. Both salts of thiamine are considered skin and respiratory sensitisers, and any exposure is considered a risk. These conclusions would apply, in principle, to any preparations produced with the thiamine mononitrate. The Panel concluded there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9347","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme tannase from the non-genetically modified Aspergillus sp. strain TAN 206","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Ana Criado,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Eleonora Marini,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9338","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9338","url":null,"abstract":"<p>The food enzyme tannase (tannin acylhydrolase; EC 3.1.1.20) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain TAN 206 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in two food manufacturing processes. Dietary exposure was estimated to be up to 0.310 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 770 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2484. A search for the homology of the amino acid sequence of the tannase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9338","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143801891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from the non-genetically modified Aspergillus niger strain AGME 1415","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Daniele Cavanna,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Natalia Kovalkovicova,&nbsp;Eleonora Marini,&nbsp;Francesco Pesce,&nbsp;Giulio di Piazza,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9334","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9334","url":null,"abstract":"<p>The food enzyme glucan 1,4-α-glucosidase (4-α-<span>d</span>-glucan α-glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified <i>Aspergillus niger</i> strain AGME 1415 by ENMEX SA de CV, a Kerry Company. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining five processes. It was estimated to be up to 7.143 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg body weight (bw) per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 280. A search for the homology of the amino acid sequence of the glucan 1,4-<i>α</i>-glucosidase to known allergens was made and one match with a respiratory allergen was found. The Panel considered that a risk of allergic reactions by dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9334","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143793312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Occurrence and spread of carbapenemase-producing Enterobacterales (CPE) in the food chain in the EU/EFTA. Part 1: 2025 update","authors":"EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards),&nbsp;Ana Allende,&nbsp;Avelino Álvarez-Ordóñez,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Alessandra De Cesare,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Lieve Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Lapo Mughini-Gras,&nbsp;Maarten Nauta,&nbsp;Jakob Ottoson,&nbsp;Fernando Pérez-Rodríguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;Hector Argüello,&nbsp;Johan Bengtsson-Palme,&nbsp;Alessandra Carattoli,&nbsp;Anke Kohlenberg,&nbsp;Dominique L. Monnet,&nbsp;Laurent Poirel,&nbsp;Beatriz Guerra,&nbsp;Raquel García-Fierro,&nbsp;Ernesto Liébana,&nbsp;Sonagnon Martin Goudjihounde,&nbsp;Núria Ferrer-Bustins,&nbsp;Hanne Rabbås,&nbsp;Luisa Peixe","doi":"10.2903/j.efsa.2025.9336","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9336","url":null,"abstract":"<p>Carbapenemase-producing Enterobacterales (CPE) have been reported in the food chain in 14 out of 30 EU/EFTA countries. Commonly reported genes are <i>bla</i>_VIM-1, <i>bla</i>_OXA-48 and <i>bla</i>_OXA-181, followed by <i>bla</i>_NDM-5 and <i>bla</i>_IMI-1. <i>Escherichia coli,</i> target of most of the studies, <i>Enterobacter cloacae</i> complex, <i>Klebsiella pneumoniae</i> complex and <i>Salmonella</i> Infantis are the most frequent CPE. <i>E. coli</i> isolates show a high clonal diversity. IncHI2 (<i>bla</i>_VIM-1 and <i>bla</i>_OXA-162), IncC (<i>bla</i>_VIM-1 and <i>bla</i>_NDM-1), IncX3 (<i>bla</i>_NDM-5 and <i>bla</i>_OXA-181), IncI and IncL (<i>bla</i>_OXA-48) plasmids are frequently reported. Most reports are from terrestrial food-producing animals and their environments – mainly pigs, followed by bovines and poultry and with occasional reports of meat thereof (targets of the EU monitoring and follow up trace back investigations). Few studies have investigated foods of aquatic animal origin and of non-animal origin, finding a great CPE diversity. A notable increase in the number of CPE detections has been observed, predominantly from pigs, with a surge in certain countries in 2021 (<i>bla</i>_OXA-181, Italy) and 2023 (<i>bla</i>_OXA-48, Spain; <i>bla</i>_OXA-181, <i>bla</i>_OXA-48, <i>bla</i>_OXA-244 and <i>bla</i>_NDM-5, Portugal). Very few data points to circumstantial evidence of CPE transmission, clonal and/or horizontal gene spread within the food chain and from/to humans. Various methods are used in the EU/EFTA countries to detect and characterise CPE in the food chain. Improvement of their sensitivity should be investigated. Ten out of 30 EU/EFTA countries have specific contingency plans for CPE control, being epidemiological investigations (e.g. trace-back) a common action included in those plans. Overall, data remain scarce for the bacterial species and sources beyond those systematically monitored. Recommendations to fill data gaps on other bacterial species and sources, dissemination pathways and optimisation of detection methods are given. A One Health approach to address the drivers of CPE spread in the food chain is needed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9336","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143793313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain LAC-01","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Simone Lunardi,&nbsp;Magdalena Andryszkiewicz,&nbsp;Eleonora Marini,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9329","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9329","url":null,"abstract":"<p>The food enzyme β-galactosidase (β-<span>d</span>-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified <i>Kluyveromyces lactis</i> strain LAC-01 by Nagase (Europa) GmbH. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.133 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern arising from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the β-galactosidase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9329","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of L-lysine sulfate produced by fermentation with Corynebacterium glutamicum CGMCC 7.453 for all animal species (Eppen Europe SAS)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Nicole Bozzi Cionci,&nbsp;Anna Dioni,&nbsp;Jordi Tarrés-Call,&nbsp;Joana P. Firmino","doi":"10.2903/j.efsa.2025.9343","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9343","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on L-lysine sulfate produced by fermentation with a genetically modified strain of <i>Corynebacterium glutamicum</i> (CGMCC 7.453) when used as a nutritional additive in feed for all animal species. The active substance is L-lysine. The FEEDAP Panel concluded that the production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment; therefore, L-lysine sulfate produced with <i>C. glutamicum</i> CGMCC 7.453 does not pose any safety concern associated with the production strain. L-Lysine sulfate produced with <i>C. glutamicum</i> CGMCC 7.453 is considered safe for the target species. The FEEDAP Panel has concerns on the use of L-lysine sulfate in water for drinking. When using L-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. L-Lysine sulfate produced with <i>C. glutamicum</i> CGMCC 7.453 is safe for the consumer and for the environment. Based on the information provided in the safety data sheet of the additive under assessment, the FEEDAP Panel concludes that the additive should be considered irritant to skin, eyes and the respiratory tract, and that any exposure to the additive is a risk. L-Lysine sulfate is considered an efficacious source of the essential amino acid L-lysine for non-ruminant animal species. For the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9343","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme cellulose 1,4-β-cellobiosidase (non-reducing end) from the non-genetically modified Trichoderma citrinoviride strain C1-5-2","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Andrew Chesson,&nbsp;Lieve Herman,&nbsp;Natália Kovalkovičová,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Simone Lunardi,&nbsp;Roos Anna de Nijs,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9333","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9333","url":null,"abstract":"<p>The food enzyme cellulose 1,4-β-cellobiosidase (non-reducing end) (EC 3.2.1.91) is produced with the non-genetically modified <i>Trichoderma citrinoviride</i> strain C1-5-2 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in ten food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.568 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1962 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 3454. A search for the homology of the amino acid sequence of the cellulose 1,4-β-cellobiosidase (non-reducing end) to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9333","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chitin estimation in agricultural soils","authors":"Alex Gobbi,&nbsp;Roberto Lava,&nbsp;Giorgia Vianello","doi":"10.2903/j.efsa.2025.9313","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9313","url":null,"abstract":"<p>The present scientific report has been elaborated in the context of the European Commission mandate requesting for an opinion according to Article 23(6) of Regulation (EC) No 1107/2009 regarding the approved plant protection uses of chitosan and chitosan hydrochloride as basic substances. This scientific report focused on estimating the amount of chitin present in an average agricultural soil, aiming to establish a baseline for its natural availability. Understanding the source and concentration of biotic chitin in soil assisted the estimation of chitosan potentially available in the environment, as requested in one of terms of reference of the concerned EC mandate. Chitin in soil was estimated to range from 27 to 280 kg/ha in the first 0–5 cm layer and 99 to 901 kg/ha in the 0–20 cm layer. Fungi are the main chitin producer followed by insects and nematodes. Soil crustaceans could not be considered in the assessment due to the lack of necessary information and the variability of their presence. The development of a polynomial function to estimate the amount of chitin in such biome can also identify the main predictors of chitin content in similar biomes. This estimate was based on the available scientific literature, and it would require additional validation using field measurements and error analysis on different soil types and conditions, to become a generalised model. Lack of information alongside related uncertainties have also been identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9313","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}